A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00504816
First received: July 13, 2007
Last updated: May 31, 2012
Last verified: February 2011
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Purpose
The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 |
Drug: GSK189075 Drug: Brevicon |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | An Open Label, Single-sequence, Repeat-dose Study to Investigate the Effects of GSK189075 on the Pharmacokinetics of an Oral Contraceptive Pill When Coadministered to Healthy Female Volunteers |
Resource links provided by NLM:
Drug Information available for:
Ethynylestradiol mixture with norethindrone
Ethinyl estradiol mixture with norethindrone
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Oral contraceptive pill (OC) drug levels [ Time Frame: over 24h starting on Day 14 ] [ Designated as safety issue: No ]
- blood hormone levels [ Time Frame: on Days 1, 11-14, & 21 of Periods 1 (OC alone) & 3 (OC plus GSK study drug). Period 2 is GSK drug study alone. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events [ Time Frame: all visits after study drug ] [ Designated as safety issue: No ]
- ECGs, Clinical laboratory tests [ Time Frame: screening & follow-up ] [ Designated as safety issue: No ]
- vital signs [ Time Frame: screening;Day 13, Period 1 & 3; Follow-up ] [ Designated as safety issue: No ]
Enrollment: | 22 |
Study Start Date: | April 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Brevicon
Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
|
Drug: GSK189075
Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
|
Experimental: GSK189075
Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.
|
Drug: Brevicon
Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
Other Names:
|
Eligibility
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
- able to take a specific oral contraceptive & KG2107494.
- female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.
- female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.
Exclusion Criteria:
- pregnant or a nursing female.
- female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.
- Have suffered with certain infection within 4 weeks prior to the first dose of study drug
Contacts and Locations
More Information
No publications provided
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00504816 History of Changes |
Other Study ID Numbers: | KG2107494 |
Study First Received: | July 13, 2007 |
Last Updated: | May 31, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
healthy female, pharmacokinetics, pharmacodynamics drug interaction, |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Contraceptive Agents Norinyl Ethynylestradiol mixture with norethindrone Contraceptives, Oral |
Contraceptives, Oral, Combined Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Contraceptives, Oral, Hormonal Contraceptives, Oral, Sequential Contraceptives, Oral, Synthetic |
ClinicalTrials.gov processed this record on October 17, 2012